Airway implant and methods of making and using

ABSTRACT

A system and device for maintaining and/or creating patency in airways is disclosed. The methods of using the system and device are also disclosed. The system includes a power source that energizes a electro-active polymer implant. The energized polymer implant provides stiffness and shape to the airway, thereby minimizing collapse or deformation of the airway. A method of making the device is also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional application of U.S. patentapplication Ser. No. 10/946,435 (Attorney Docket No. 026705-000300US),filed on Sep. 21, 2004, the full disclosures of which is incorporatedherein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to the systems, devices and methods for creatingand/or maintaining airway patency, for example, for treating snoringand/or sleep apnea.

2. Description of the Related Art

Snoring is very common among mammals including humans. Snoring is anoise produced while breathing during sleep causes vibration of the softpalate and uvula. Not all snoring is bad, except it bothers the bedpartner or others near the person who is snoring. If the snoring getsworst overtime and goes untreated, it could lead to apnea.

Those with apnea stop breathing in their sleep, often hundreds of timesduring the night. Usually apnea occurs when the throat muscles andtongue relax during sleep and partially block the opening of the airway.When the muscles of the soft palate at the base of the tongue and theuvula relax and sag, the airway becomes blocked, making breathinglabored and noisy and even stopping it altogether. Sleep apnea also canoccur in obese people when an excess amount of tissue in the airwaycauses it to be narrowed.

In a given night, the number of involuntary breathing pauses or “apneicevents” may be as high as 20 to 60 or more per hour. These breathingpauses are almost always accompanied by snoring between apnea episodes.Sleep apnea can also be characterized by choking sensations.

Sleep apnea is diagnosed and treated by primary care physician,pulmonologists, neurologists, or other physicians with specialtytraining in sleep disorders. Diagnosis of sleep apnea is not simplebecause there can be many different reasons for disturbed sleep.

The specific therapy for sleep apnea is tailored to the individualpatient based on medical history, physical examination, and the resultsof polysomnography. Medications are generally not effective in thetreatment of sleep apnea. Oxygen is sometimes used in patients withcentral apnea caused by heart failure. It is not used to treatobstructive sleep apnea.

Nasal continuous positive airway pressure (CPAP) is the most commontreatment for sleep apnea. In this procedure, the patient wears a maskover the nose during sleep, and pressure from an air blower forces airthrough the nasal passages. The air pressure is adjusted so that it isjust enough to prevent the throat from collapsing during sleep. Thepressure is constant and continuous. Nasal CPAP prevents airway closurewhile in use, but apnea episodes return when CPAP is stopped or it isused improperly. Many variations of the CPAP devices are available andall have the same side effects such as nasal irritation and drying,facial skin irritation, abdominal bloating, mask leaks, sore eyes, andheadaches. Some versions of CPAP vary the pressure to coincide with theperson's breathing pattern, and other CPAPs start with low pressure,slowly increasing it to allow the person to fall asleep before the fullprescribed pressure is applied.

Dental appliances that reposition the lower jaw and the tongue have beenhelpful to some patients with mild to moderate sleep apnea or who snorebut do not have apnea. A dentist or orthodontist is often the one to fitthe patient with such a device.

Some patients with sleep apnea may need surgery. Although severalsurgical procedures are used to increase the size of the airway, none ofthem is completely successful or without risks. More than one proceduremay need to be tried before the patient realizes any benefits. Some ofthe more common procedures include removal of adenoids and tonsils(especially in children), nasal polyps or other growths, or other tissuein the airway and correction of structural deformities. Younger patientsseem to benefit from these surgical procedures more than older patients.

Uvulopalatopharyngoplasty (UPPP) is a procedure used to remove excesstissue at the back of the throat (tonsils, uvula, and part of the softpalate). The success of this technique may range from 30 to 60 percent.The long-term side effects and benefits are not known, and it isdifficult to predict which patients will do well with this procedure.

Laser-assisted uvulopalatoplasty (LAUD) is done to eliminate snoring buthas not been shown to be effective in treating sleep apnea. Thisprocedure involves using a laser device to eliminate tissue in the backof the throat. Like UPPP, LAUD may decrease or eliminate snoring but noteliminate sleep apnea itself. Elimination of snoring, the primarysymptom of sleep apnea, without influencing the condition may carry therisk of delaying the diagnosis and possible treatment of sleep apnea inpatients who elect to have LAUP. To identify possible underlying sleepapnea, sleep studies are usually required before LAUP is performed.

Somnoplasty is a procedure that uses RF to reduce the size of someairway structures such as the uvula and the back of the tongue. Thistechnique helps in reducing snoring and is being investigated as atreatment for apnea.

Tracheostomy is used in persons with severe, life-threatening sleepapnea. In this procedure, a small hole is made in the windpipe and atube is inserted into the opening. This tube stays closed during wakinghours and the person breathes and speaks normally. It is opened forsleep so that air flows directly into the lungs, bypassing any upperairway obstruction. Although this procedure is highly effective, it isan extreme measure that is rarely used.

Patients in whom sleep apnea is due to deformities of the lower jaw maybenefit from surgical reconstruction. Surgical procedures to treatobesity are sometimes recommended for sleep apnea patients who aremorbidly obese. Behavioral changes are an important part of thetreatment program, and in mild cases behavioral therapy may be all thatis needed. Overweight persons can benefit from losing weight. Even a 10percent weight loss can reduce the number of apneic events for mostpatients. Individuals with apnea should avoid the use of alcohol andsleeping pills, which make the airway more likely to collapse duringsleep and prolong the apneic periods. In some patients with mild sleepapnea, breathing pauses occur only when they sleep on their backs. Insuch cases, using pillows and other devices that help them sleep in aside position may be helpful.

Recently, company—Restore Medical, Inc., Saint Paul, Minn.—has developeda new treatment for snoring and apnea and the technique is calledPillar™ technique. Pillar™ System is a minimally invasive procedurewhere 2 or 3 small polyester rod type devices are placed in patient'ssoft palate. The Pillar™ System stiffens the palate and reduces thevibration of the tissue and prevents the possible airway collapse. Stiffimplants in the soft palate could hinder patient's normal functions likespeech, ability to swallow, coughing and sneezing. Protrusion in theairway is another long-term concern.

BRIEF SUMMARY OF THE INVENTION

A new type of implant to treat patients with snoring and/or apnea isdisclosed. An electroactive polymeric (EAP) device can be inserted inthe soft palate and/or sidewalls of the patient's airway. The polymericimplant can have a very low stiffness under normal conditions. When thepolymeric device is energized, the polymer can become stiff and tend todeform. The polymeric device, in its energized state, can have theability to support the weight of the soft palate and sidewalls of thepatient. When the charge is removed, the polymeric device can becomesoft and not interfere with the patient's normal activities likeswallowing and speech.

Electroactive polymer (EAP) is a type of polymer that can respond toelectrical stimulation by physical deformation, change in tensileproperties and change in hardness. There are several types ofelectroactive polymers like dielectric electrostrictive polymer, ionexchange polymer and ion exchange polymer metal composite (IPMC). Theparticular type of EAP used in the making of the disclosed device can beany of the aforementioned electroactive polymers, such as IPMC.

IPMC is a polymer and metal composite that uses an ionomer as the basematerial. Ionomers are types of polymers that allow for ion movementthrough the membrane. There are several ionomers available in the marketand some of the suited ionomers for this application are polyethylene,polystyrene, polytetrafluoroethylene, polyvinylidene fluoride,polyfluorosulfonic acid based membranes like NAFION® (from E.I. Du Pontde Nemours and Company, Wilmington, Del.), polyaniline,polyacrylonitrile, cellulose, cellulose acetates, regenerated cellulose,polysulfone, polyurethane, or combinations thereof. A conductive metal,for example, gold, silver, platinum, palladium, copper, carbon, orcombinations thereof, can be deposited on the ionomer to make the IPMC.

The IPMC element can be formed in many shapes, for example, a strip,rod, cylindrical tube, rectangular piece, triangular piece, trapezoidalshape, arch shapes, coil shapes, or combinations thereof. The IPMCelement can have perforations or slots cut in them to allow tissue ingrowth.

One or more implants can be placed in the soft palate, sidewalls of theairway, around the trachea, in the tongue, in the uvula, or incombinations thereof. The implant can have lead wires (e.g., anode andcathode) attached to the surfaces. The lead wires can be connected to aninduction coil. The induction coil can be implanted in the roof of themouth. The patient can wear a specially fitted retainer type of devicebefore going to bed every night. The retainer can have an inductioncoil, a circuit and a battery. When the patient wears the retainer, theinduction coil in the retainer is aligned with the induction coil thatis implanted in the roof of the mouth. The energy can be transmittedthrough the tissue and to the coil that is in the roof of the mouth. TheIPMC implant can be energized, deform and stiffen to provide support.Patient can relax and sleep without the worry of the airway collapse intheir sleep. In the morning when the patient wakes up, the patient canremove the retainer and place the retainer on a charging unit torecharge the battery.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 through 3 illustrate various embodiments of the patency system.

FIG. 4 illustrates an embodiment of the patency system.

FIG. 5 illustrates a circuit diagram of an embodiment of the patencysystem in use.

FIG. 6 illustrates an embodiment of the patency system.

FIGS. 7 and 8 illustrate various sectional views of the patency element.

FIGS. 9 through 19 illustrate perspective views of various embodimentsof the patency element.

FIGS. 20 and 21 illustrate various embodiments of the implanted portionof the patency system.

FIGS. 22 through 24 illustrate various embodiments of the secondtransducers.

FIG. 25 shows a sagittal section through a head of a subjectillustrating an embodiment of a method for using the patency system.

FIGS. 26 through 29 illustrate anterior views of the mouth withsee-though mouth roofs of various embodiments of methods for using thepatency system.

FIG. 30 illustrates an embodiment of a method for using the patencysystem.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates an electro-active patency system 2 that can have apower supply 4, a connecting element, such as a wire lead 6, and apatency element 8 that can be made from an electro-active polymer.

The power supply 4 can be a power cell, a battery, a capacitor, asubstantially infinite bus (e.g., a wall outlet leading to a powergenerator), a generator (e.g., a portable generator, a solar generator,an internal combustion generator), or combinations thereof. The powersupply 4 can have a power output of from about 1 mA to about 5 A, forexample, about 500 mA.

The connecting element can be the wire lead 6, an inductive energytransfer system, a conductive energy transfer system, a chemical energytransfer system, an acoustic or otherwise vibratory energy transfersystem, a nerve or nerve pathway, other biological tissue, orcombinations thereof. The connecting element can be made from one ormore conductive materials, such as copper. The connecting element can becompletely or partially insulated and or protected by an insulator, forexample, polytetrafluoroethylene (PTFE). The insulator can bebiocompatible. The power supply 4 can be in electrical communicationwith the patency element 8 through the connecting element. Theconnecting element can be attached to an anode 10 and a cathode 12 onthe power supply 4. The connecting element can be made from one or moresub-elements.

The patency element 8 can be made from an electro-active polymer. Theelectroactive polymer can have an ion exchange polymer metal composite(IPMC). The IPMC can have a base polymer embedded, or otherwiseappropriately mixed, with a metal. The IPMC base polymer can beperfluoronated polymer, polytetrafluoroethylene, polyfluorosulfonicacid, perfluorosulfonate, polyvinylidene fluoride, hydrophilicpolyvinylidene fluoride, polyethylene, polypropylene, polystyrene,polyaniline, polyacrylonitrile, cellophane, cellulose, regeneratedcellulose, cellulose acetate, polysulfone, polyurethane, polyvinylalcohol, polyvinyl acetate and polyvinyl pyrrolidone, or combinationsthereof. The IPMC metal can be platinum, gold, silver, palladium,copper, carbon, or combinations thereof.

FIG. 2 illustrates that the patency system 2 can have multiple patencyelements 8 and connecting elements 14 that can all connect to a singlepower supply 4.

FIG. 3 illustrates that the patency system 2 can have multiple powersupplies 4 and connecting elements 14 that can all connect to a singlepatency element 8. The patency system 2 can have any number andcombination of patency elements 8 connected to power supplies 4.

FIG. 4 illustrates that the connecting element can have a first energytransfer element, for example, a first transducer such as a firstreceiver, and a second energy transfer element, for example, a secondtransducer such as a second inductor 16. The first receiver can be afirst inductor 18. The first inductor 18 can be positioned close enoughto the second inductor 16 to enable sufficient inductive electricitytransfer between the second and first inductors 16 and 18 to energizethe patency element 8.

FIG. 5 illustrates that the patency system of FIG. 4 can have animplanted portion 20 and a non-implanted portion 22. The implantedportion 20 can be a closed circuit with the first inductor 18 in serieswith a first capacitor 24 and the patency element 8. The patency element8 can be attached to the closed circuit of the implanted portion 20 by afirst contact 26 and a second contact 28. The implanted portion can havea resistor (not shown).

The non-implanted portion 22 can be a closed circuit. The non-implantedportion 22 can have a second inductor 16 that can be in series with aresistor 30, the power supply 4, and a second capacitor 32. Thecapacitors, resistors, and, in-part, the inductors can be representativeof the electrical characteristics of the wire of the circuit and notnecessarily representative of specific elements.

The implanted portion 20 can be within tissue and have a tissue surface33 nearby. The non-implanted portion can be in insulation material 35.An air interface 37 can be between the tissue surface 33 and theinsulation material 35.

FIG. 6 illustrates that the first energy transfer element of theconnecting element 14 can be a first conductor 34. The second energytransfer element of the connecting element 14 can be a second conductor36. The first conductor 34 can be configured to plug into, receive, orotherwise make secure electrical conductive contact with the secondconductor 36. The first conductor 34 and/or second conductor 36 can beplugs, sockets, conductive dental fillings, tooth caps, fake teeth, orany combination thereof.

FIG. 7 illustrates that the patency element 8 can be a multi-layereddevice. The patency element 8 can have a first EAP layer 38, a secondEAP layer 40, and a third EAP layer 42. The EAP layers 38, 40 and 42 canbe in contact with each other and not separated by an insulator.

FIG. 8 illustrates that the patency element 8 can have a first EAP layer38 separated from a second EAP layer 40 by a first insulation layer 44.A second insulation layer 46 can separate the second EAP layer from thethird EAP layer 42. A third insulation layer 48 can separate the thirdEAP layer from the fourth EAP layer 50. Insulation material can be apolymeric material that electrically isolates each layer. The insulationcan be, for example, acrylic polymers, polyimide, polypropylene,polyethylene, silicones, nylons, polyesters, polyurethanes, orcombinations thereof. Each EAP layer, 38, 40, 42 and 50 can be connectedto a lead wire (not shown). All anodes and all cathodes can be connectedto the power supply 4.

FIG. 9 illustrates that the patency element 8 can have a substantiallyflat rectangular configuration. The patency element 8 can have a widthfrom about 2 mm to about 5 cm, for example, about 1 cm. FIG. 10illustrates that the patency element 8 can have an “S” or zigzag shape.FIG. 11 illustrates that the patency element 8 can have an oval shape.FIG. 12 illustrates that the patency element 8 can have a substantiallyflat rectangular shape with slots 52 cut perpendicular to thelongitudinal axis of the patency element 8. The slots 52 can originatenear the longitudinal axis of the patency element 8. The patency element8 can have legs 54 extending away from the longitudinal axis.

FIG. 13 illustrates that the patency element 8 can have slots 52 andlegs 54 parallel with the longitudinal axis. FIG. 14 illustrates thatthe patency element can be configured as a quadrilateral, such as atrapezoid. The patency element 8 can have chamfered corners, as shown byradius. FIG. 15 illustrates that the patency element 8 can haveapertures 55, holes, perforations, or combinations thereof. FIG. 16illustrates that the patency element 8 can have slots 52 and legs 54extending from a side of the patency element 8 parallel with thelongitudinal axis.

FIG. 17 illustrates that the patency element 8 can be a hollow cylinder,tube or rod. The patency element can have an inner diameter 56.

FIG. 18 illustrates an arched patency element 8. The arch can have aradius of curvature 57 from about 1 cm to about 10 cm, for example,about 4 cm. The patency element 8 can have a uniform thickness.

FIG. 19 illustrates an arched patency element 8. The patency element 8can have a varying thickness. A first thickness 58 can be equal orgreater than a second thickness 60.

FIG. 20 illustrates that the implanted portion can have a coil-typeinductor 18 connected by the wire lead 6 to the patency element 8.

FIG. 21 illustrates that the implanted portion can have a conductivedental filling 62 in a tooth 64. The dental filling 62 can be previouslyimplanted for reasons related or unrelated to airway patency. The dentalfilling 62 can be electrically connected to the wire lead 6. Forexample, the a portion of the wire lead 6 can be implanted in the tooth64, as shown by phantom line. The wire lead 6 can be connected to thepatency element 8.

FIG. 22 illustrates that the non-implanted portion 22 can have amouthpiece, such as a retainer 66. The retainer 66 can be customconfigured to fit to the patient's mouth roof, or another part of thepatient's mouth. The second transducer, such as second inductor 16, canbe integral with, or attached to, the retainer 66. The second inductor16 can be located in the retainer 66 so that during use the secondinductor 16 can be substantially aligned with the first inductor 18. Thepower supply 4, such as a cell, can be integral with, or attached to,the retainer 66. The power supply 4 can be in electrical communicationwith the second inductor 16. The retainer 66 can have apulsewidth-modulation circuit.

FIG. 23 illustrates that the retainer 66 can have one or more toothsockets 68. The tooth sockets 68 can be configured to receive teeth thathave dental fillings. The tooth sockets 68 can be electricallyconductive in areas where they align with dental fillings when in use.The power supply 4 can be connected with the tooth sockets 68 via thewire leads 6.

FIG. 24 illustrates that the non-implantable portion 22 can have thesecond inductor 16 attached to a removably attachable patch 70. Thepatch 70 can be attached to the power supply 4. The power supply 4 canbe in contact with the second inductor 16.

Method of Making

The patency element 8, for example, an IPMC strip, can be made from abase material of an ionomer sheet, film or membrane. The ionomer sheetcan be formed using ionomer dispersion.

IPMC can be made from the base ionomer of, for example, polyethylene,polystyrene, polytetrafluoroethylene, polyvinylidene fluoride (PVDF)(e.g., KYNAR® and KYNAR Flex®, from ATOFINA, Paris, France, and SOLEFO,from Solvay Solexis S.A., Brussels, Belgium), hydrophilic-PVDF (h-PVDF),polyfluorosulfonic acid based membranes like NAFIONO (from E.I. Du Pontde Nemours and Company, Wilmington, Del.), polyaniline,polyacrylonitrile, cellulose, cellulose acetates, regenerated cellulose,polysulfone, polyurethane, and combinations thereof. The conductivematerial that is deposited on the ionomer can be gold, platinum, silver,palladium, copper, graphite, conductive carbon, or combinations thereof.Conductive material can be deposited on the ionomer either byelectrolysis process, vapor deposition, sputtering, electroplating, orcombination of processes.

The IPMC can be cut into the desired implant shape, such as those shownin FIGS. 9 through 19. The wire leads 6 (e.g., anode and cathode wiresfor each patency element) can be connected to the IPMC surfaces by, forexample, soldering, welding, brazing, potting using conductiveadhesives, or combinations thereof. The patency element 8 can beconfigured into specific curved shapes using mold and heat settingprocesses.

The patency element 8 can be insulated with electrical insulationcoatings. The patency element 8 can be insulated with coatings thatpromote cell growth and minimize fibrosis, stop cell growth, or killnearby cells. The patency element 8 can be insulated with abiocompatible material. The patency element 8 can be coated withpolymers such as polypropylene, poly-L-lysine, poly-D-lysine,polyethylene glycol, povinyl alcohol, polyvinyl acetate, polymethylmethacrylate, or combinations thereof. The patency element can be coatedwith hyaluronic acid. The coating can be applied to the device bystandard coating techniques like spraying, electrostatic spraying,brushing, vapor deposition, dipping, etc.

In one example, a perfluorosulfonate ionomer, PVDF or h-PVDF sheet canbe prepared for manufacturing the patency element 8. The sheet can beroughened on both sides using, for example, about 320-grit sand paperand then about 600-grit sand paper. The sheet can then be rinsed withdeionized water. The sheet can then be submerged in isopropyl alcohol(IPA), and subjected to an ultrasonic bath for about 10 minutes. Thesheet can then be rinsed with deionized water. The sheet can then beboiled for about 30 minutes in hydrochloric acid (HCL). The sheet canthen be rinsed and then boiled in deionized water for about 30 minutes.

The sheet can then be subject to ion-exchange (i.e., absorption). Thesheet can be submerged into, or otherwise exposed to, a metal saltsolution at room temperature for more than about three hours. Examplesof the metal salt solution are tetraammineplatinum chloride solution,silver chloride solution, hydrogen tetrachloroaurate,tetraamminepalladium chloride monohydrate or other platinum, gold,silver, carbon, copper, or palladium salts in solution. The metal saltsolution can have a concentration of greater than or equal to about 200mg/100 ml water. 5% ammonium hydroxide solution can be added at a ratioof 2.5 ml/100 ml to the tetraammineplatinum chloride solution toneutralize the solution. The sheet can then be rinsed with deionizedwater.

A primary plating can then be applied to the sheet. The sheet can besubmerged in water at about 40° C. A 5% solution by weight of sodiumborohydride and deionized water can be added to the water submerging thesheet at 2 ml/180 ml of water. The solution can stir for 30 minutes at40° C. The sodium borohydride solution can then be added to the water at2 ml/180 ml of water and the solution can stir for 30 minutes at 40° C.This sodium borohydride adding and solution stirring can be performedsix times total. The water temperature can then be gradually raised to60° C. 20 ml of the sodium borohydride solution can then be added to thewater. The solution can stir for about 90 minutes. The sheet can then berinsed with deionized water, submerged into 0.1N HCl for an hour, andthen rinsed with deionized water.

The sheet can then receive a second plating. The sheet can be submergedor otherwise exposed to a tetraammineplatinum chloride solution at aconcentration of about 50 mg/100 ml deionized water. 5% ammoniumhydroxide solution can be added at a rate of 2 ml/100 ml oftetraammineplatinum chloride solution. 5% by volume solution ofhydroxylamine hydrochloride in deionized water can be added to thetetraammmeplatinum chloride solution at a ratio of 0.1 of the volume ofthe tetraammineplatinum chloride solution. 20% by volume solution ofhydrazine monohydrate in deionized water can be added to thetetraammineplatinum chloride solution at a ratio of 0.05 of the volumeof the tetraammineplatinum chloride solution. The temperature can thenbe set to about 40° C. and the solution can be stirred.

A 5% solution of hydroxylamine hydrochloride can then be added at aratio of 2.5 ml/100 ml of tetraammineplatinum chloride solution. A 20%solution of hydrazine monohydrate solution can then be added at a ratioof 1.25 ml/100 ml tetraammineplatinum chloride solution. The solutioncan be stirred for 30 minutes and the temperature set to 60° C. Theabove steps in this paragraph can then be repeated three additionaltimes. The sheet can then be rinsed with deionized water, boiled in HClfor 10 minutes, rinsed with deionized water and dried.

The polymer base can be dissolved in solvents, for example, dimethylacetamide, acetone, methylethyle ketone, toluene, dimethyl carbonate,diethyl carbonate, and combinations thereof. The solvent can then beallowed to dry, producing a thin film. While the solution is wet, a lowfriction (e.g., glass, Teflon) plate can be dipped into the solution andremoved. The coating on the plate can dry, creating a thin film. Theplate can be repeatedly dipped into the solution to increase thethickness of the film.

Polyvinyl alcohol, polyvinyl pyrrolidone, polyvinyl acetate orcombinations thereof can be added to a PVDF solution before drying, thuscontributing hydrophilic properties to PVDF and can improve ionmigration through the polymer film during manufacture. Dye or othercolor pigments can be added to the polymer solution.

Method of Using

FIG. 25 illustrates that the first inductor 18 can be implanted in themouth roof 72, for example, in or adjacent to the hard palate 74. Wireleads 6 can connect the first inductor 18 to the patency elements 8. Afirst patency element 8 a can be implanted in the base of the tongue atthe pharynx wall 76. A second patency element 8 b can be integral withthe first patency element 8 a (e.g., as two sections of a hollowcylindrical patency element 8, such as shown in FIG. 17). The first andsecond patency elements 8 a and 8 b can be separate and unattachedelements. The third patency element 8 c can be implanted in the uvulaand/or soft palate 84. The patency elements 8 can also be implanted inthe wall of the nasal passages 78, higher or lower in the pharynx 79,such as in the nasal pharynx, in the wall of the trachea 80, in thelarynx (not shown), in any other airway, or combinations thereof.

The second inductor 16 can be worn by the patient in the mouth 82. Thesecond inductor 16 can be connected to an integral or non-integral powersupply. The second inductor 16 can be one or multiple induction coils.The second inductor 16 can inductively transmit RF energy to the firstinductor 18. The first inductor 18 can change the RF energy intoelectricity. The first inductor 18 can send a charge or current alongthe wire leads 6 to the patency elements 8. The patency elements 8 canbe energized by the charge or current. The energized patency elements 8can increase the stiffness and/or alter the shape of the patencyelements 8. The energized patency elements 8 can create and or maintainpatency of the airway around which the patency elements 8 are implanted.

The non-energized patency elements 8 can be configured to conform to theairway around which the patency elements 8 are implanted. Thenon-energized patency elements 8 can be flexible and soft.

FIG. 26 illustrates that the first inductor 18 can be implanted in themouth roof 72 and attached to a single patency element 8 via the wirelead 6. The patency element 8 can be in the soft palate 84, orelsewhere.

FIG. 27 illustrates that the first inductor 18 can be implanted in themouth roof 72 and attached to two patency elements 8 via two wire leads6. The patency elements 8 can be implanted in side walls 86 of the mouth82.

FIG. 28 illustrates that the first inductor 18 can be implanted in themouth roof 72 and attached to three patency elements 8 via three wireleads 6. The patency elements 8 can be implanted in the soft palate 84and the side walls 86 of the mouth 82.

FIG. 29 illustrates that the first conductors 34 (not shown, e.g., thetooth sockets 68), can be attached to, and in conductive electricalcommunication with, the second conductors 36. The retainer 66, such asshown in FIG. 23, can be worn by the patient to energize the patencyelement 8. The tooth sockets 68 can removably attach to the firstconductors 34. The first conductors 34 can be dental fillings 62,conductive posts adjacent to and/or through the teeth 64.

FIG. 30 illustrates that a patient 88 with the first transducer (notshown) implanted in the patient's cheek can wear the non-implantedportion 22, such as shown in FIG. 24, on the outside of the patient'scheek. The non-implanted portion 22 can energize the implanted portion20.

It is apparent to one skilled in the art that various changes andmodifications can be made to this disclosure, and equivalents employed,without departing from the spirit and scope of the invention. Elementsshown with any embodiment are exemplary for the specific embodiment andcan be used on other embodiments within this disclosure.

1. An implantable device for maintaining and/or creating airway patencyof a biological subject, comprising: a patency element that changesshape in response to an electrical stimulus and comprises anelectro-active polymer.
 2. The device of claim 1, wherein theelectro-active polymer comprises an ion exchange polymer.
 3. The deviceof claim 1, wherein the electro-active polymer comprises an ion exchangepolymer metal composite.
 4. The device of claim 1, wherein theelectro-active polymer comprises an ionomer base material.
 5. The deviceof claim 1, wherein the electro-active polymer comprises perfluorinatedpolymer.
 6. The device of claim 1, wherein the electro-active polymercomprises polytetrafluoroethylene.
 7. The device of claim 1, wherein theelectro-active polymer comprises polyfluorosulfonic acid.
 8. The deviceof claim 1, wherein the electro-active polymer comprisesperfluorosulfonate.
 9. The device of claim 1, wherein the electro-activepolymer comprises polyvinylidene fluoride.
 10. The device of claim 1,wherein the electro-active polymer comprises hydrophilic polyvinylidenefluoride.
 11. The device of claim 1, wherein the electro-active polymercomprises polyethylene.
 12. The device of claim 1, wherein theelectro-active polymer comprises polypropylene.
 13. The device of claim1, wherein the electro-active polymer comprises polystyrene.
 14. Thedevice of claim 1, wherein the electro-active polymer comprisespolyaniline.
 15. The device of claim 1, wherein the electro-activepolymer comprises polyacrylonitrile.
 16. The device of claim 1, whereinthe electro-active polymer comprises cellophane.
 17. The device of claim1, wherein the electro-active polymer comprises cellulose.
 18. Thedevice of claim 1, wherein the electro-active polymer comprisesregenerated cellulose.
 19. The device of claim 1, wherein theelectro-active polymer comprises cellulose acetate.
 20. The device ofclaim 1, wherein the electro-active polymer comprises polysulfone. 21.The device of claim 1, wherein the electro-active polymer comprisespolyurethane.
 22. The device of claim 1, wherein the electro-activepolymer comprises polyvinyl alcohol.
 23. The device of claim 1, whereinthe electro-active polymer comprises polyvinyl acetate.
 24. The deviceof claim 1, wherein the electro-active polymer comprises polyvinylpyrrolidone.
 25. The device of claim 1, wherein the electro-activepolymer comprises a biocompatible conductive material.
 26. The device ofclaim 25, wherein the biocompatible conductive material comprisesplatinum.
 27. The device of claim 25, wherein the biocompatibleconductive material comprises gold.
 28. The device of claim 25, whereinthe biocompatible conductive material comprises silver.
 29. The deviceof claim 25, wherein the biocompatible conductive material comprisespalladium.
 30. The device of claim 25, wherein the biocompatibleconductive material comprises copper.
 31. The device of claim 25,wherein the biocompatible conductive material comprises carbon.
 32. Thedevice of claim 1, wherein the patency element comprises a threedimensional shape.
 33. The device of claim 1, wherein the patencyelement comprises a substantially rectangular shape.
 34. The device ofclaim 1, wherein the patency element comprises a substantiallytriangular shape.
 34. The device of claim 1, wherein the patency elementcomprises a substantially round shape.
 35. The device of claim 1,wherein the patency element comprises a substantially trapezoidal shape.36. The device of claim 1, wherein the patency element comprises a shapeslots that are perpendicular to the axis.
 37. The device of claim 1,wherein the patency element comprises slots that are parallel to thelongitudinal axis.
 38. The device of claim 1, wherein the patencyelement comprises a flat strip.
 39. The device of claim 1, wherein thepatency element comprises a rod.
 40. The device of claim 1, wherein thepatency element comprises a cylindrical tube.
 41. The device of claim 1,wherein the patency element comprises an arch.
 42. The device of claim42, wherein the arch has a uniform thickness.
 43. The device of claim42, wherein the arch has a varying thickness.
 44. The device of claim 1,wherein the patency element comprises a coil.
 45. The device of claim 1,wherein the patency element comprises perforations.
 46. The device ofclaim 1, wherein the patency element comprises slots.
 47. The device ofclaim 1, wherein the patency element comprises a first layer of theelectroactive polymer.
 48. The device of claim 48, wherein the patencyelement comprises a second layer of the electroactive polymer.
 49. Thedevice of claim 48, wherein the patency element comprises an insulationlayer separating the first layer of the electroactive polymer from thesecond layer of the electroactive polymer.
 50. The device of claim 50,wherein the insulation layer comprises silicone.
 51. The device of claim50, wherein the insulation layer comprises polyurethane.
 52. The deviceof claim 50, wherein the insulation layer comprises polyimide.
 53. Thedevice of claim 50, wherein the insulation layer comprises nylon. 54.The device of claim 50, wherein the insulation layer comprisespolyester.
 55. The device of claim 50, wherein the insulation layercomprises polymethylmethacrylate.
 56. The device of claim 50, whereinthe insulation layer comprises polymethylmethacrylate.
 57. The device ofclaim 50, wherein the insulation layer comprises neoprene.
 58. Thedevice of claim 50, wherein the insulation layer comprises styrenebutadiene styrene.
 59. The device of claim 50, wherein the insulationlayer comprises polyvinyl acetate.
 60. The device of claim 1, whereinthe patency element has a non-energized configuration, and wherein thepatency element is soft in the non-energized configuration.
 61. Thedevice of claim 1, wherein the patency element has an energizedconfiguration, and wherein the patency element in the energizedconfiguration is stiffer than the patency element in the non-energizedconfiguration.
 62. The device of claim 1, wherein the patency elementhas a pre-set non-energized configuration, and wherein the patencyelement is soft in the pre-set non-energized configuration.
 63. Thedevice of claim 63, wherein the pre-set non-energized configuration issubstantially similar to the geometry of the patient's airway where thedevice is implanted.
 64. The device of claim 64, wherein the patencyelement has a pre-set energized configuration when the patency elementis energized, and wherein the patency element in the pre-set energizedconfiguration is stiffer than the patency element in the pre-setnon-energized configuration.
 65. The device of claim 63, wherein thepatency element in the pre-set non-energized configuration issubstantially equal to the patency element in the energizedconfiguration.
 66. The device of claim 66, wherein the pre-setnon-energized configuration is substantially similar to the geometry ofthe airway where the device is implanted.
 67. The device of claim 1,wherein the patency element comprises a coating.
 68. The device of claim68, wherein the coating isolates the patency element from body fluids.69. The device of claim 68, wherein the coating's dielectric strength issufficient enough to electrically isolate the patency element.
 70. Thedevice of claim 68, wherein the coating is configured to minimize tissuegrowth on the patency element.
 71. The device of claim 68, wherein thecoating is configured to promote tissue growth on the patency element.72. The device of claim 68, wherein the coating comprises poly-L-lysine.73. The device of claim 68, wherein the coating comprises poly-D-lysine.74. The device of claim 68, wherein the coating comprises polyethyleneglycol.
 75. The device of claim 68, wherein the coating comprisespolyvinyl alcohol.
 76. The device of claim 68, wherein the coatingcomprises polyvinyl acetate.
 77. The device of claim 68, wherein thecoating comprises hyaluronic acid.
 78. The device of claim 68, whereinthe coating comprises methylmethacrylate.
 79. An implantable device formaintaining and/or creating patency of a lumen of a biological subject,comprising: an electro-active patency element; and an implantabletransducer in electrical communication with the patency element.
 80. Thedevice of claim 80, wherein the lumen comprises an airway.
 81. Thedevice of claim 80, wherein the patency element comprises anelectro-active polymer.
 82. The device of claim 82, wherein theelectro-active polymer comprises an ion exchange polymer-metalcomposite.
 83. The device of claim 80, further comprising a conductivelead attached to the electroactive patency element and the implantabletransducer.
 84. The device of claim 80, further comprising a conductivelead in electrical communication with the electro-active patency elementand the implantable transducer.
 85. The device of claim 80, furthercomprising a power supply in electrical communication with theelectro-active patency element.
 86. The device of claim 86, wherein thepower supply comprises a battery.
 87. The device of claim 86, whereinthe power supply comprises a capacitor.
 88. The device of claim 80,further comprising a battery in electrical communication with theimplantable transducer.
 89. The device of claim 80, further comprising amouthpiece in communication with the implantable transducer.
 90. Thedevice of claim 90, wherein the mouthpiece comprises a dental retainer.91. The device of claim 91, wherein the dental retainer comprising ainduction coil and a power source.
 92. The device of claim 92, whereinthe power source is a disposable battery.
 93. The device of claim 92,wherein the power source is a rechargeable battery.
 94. The device ofclaim 91, wherein the dental retainer further comprising apulsewidth-modulation circuit.
 95. The device of claim 91, wherein thedental retainer is custom fit for the individual biological subject. 96.The device of claim 90, wherein the mouthpiece is in conductiveelectrical communication with the implantable transducer.
 97. The deviceof claim 90, wherein the mouthpiece is in inductive electricalcommunication with the implantable transducer.
 98. The device of claim80, wherein the implantable transducer comprises an inductive receiver.99. The device of claim 99, wherein the inductive receiver comprises acoil.
 100. The device of claim 80, wherein the implantable transducercomprises a conductive receiver.
 101. The device of claim 101, whereinthe conductive receiver comprises a dental filling.
 102. The device ofclaim 101, wherein the conductive receiver comprises a dental implant.103. The device of claim 101, wherein the conductive receiver implantedin the oral cavity.
 104. The device of claim 101, wherein the conductivereceiver implanted in the head and neck region of the biologicalsubject.
 105. The device of claim 80, further comprising a dermal patchin communication with the implantable transducer.
 106. The device ofclaim 106, wherein the dermal patch comprises a coil, circuit and powersource.
 107. The device of claim 107, wherein the power source comprisesa battery.
 108. The device of claim 107, wherein the dermal patchfurther comprises a pulsewidth-modulation circuit.
 109. The device ofclaim 107, wherein the coil is in inductive communication with thepatency element.
 110. The device of claim 107, wherein the coil is inconductive communication with the patency element.
 111. A method formaintaining or creating airway patency in a biological subject,comprising: implanting in the biological subject a patency element thatchanges shape in response to an electrical stimulus and comprises anelectroactive polymer; and energizing the patency element.
 112. Themethod of claim 112, further comprising inserting a mouthpiece into themouth of the biological subject.
 113. The method of claim 112, whereinenergizing the patency element comprises placing the patency element inelectrical communication with a power supply.
 114. The method of claim114, wherein placing the patency element in electrical communicationwith a power supply comprises inserting a mouthpiece into the mouth ofthe biological subject.
 115. The method of claim 114, wherein theelectrical communication between the patency element and the powersupply comprises inductive communication.
 116. The method of claim 114,wherein the electrical communication between the patency element and thepower supply comprises conductive communication.
 117. The method ofclaim 112, further comprising implanting a transducer in the biologicalsubject.
 118. The method of claim 118, further comprising placing thetransducer in electrical communication with the patency element. 119.The method of claim 118, wherein energizing the patency elementcomprises placing the transducer in electrical communication with apower supply.
 120. The method of claim 112, further comprisingimplanting a power supply in the biological subject.
 121. The method ofclaim 121, further comprising charging the power supply.
 122. The methodof claim 122, wherein charging the power supply comprises wearing amouthpiece.
 123. The method of claim 112, wherein the patency element isimplanted at least in-part in a soft palate of the biological subject.124. The method of claim 112, wherein the patency element is implantedat least in-part in an airway sidewall of the biological subject. 125.The method of claim 112, wherein the patency element is implanted atleast in-part in a uvula of the biological subject.
 126. The method ofclaim 112, wherein the patency element is implanted at least in-part ina pharynx wall of the biological subject.
 127. The method of claim 112,wherein the patency element is implanted at least in-part in a tracheawall of the biological subject.
 128. The method of claim 112, whereinthe patency element is implanted at least in-part in a larynx wall ofthe biological subject.
 129. The method of claim 112, wherein thepatency element is implanted at least in-part in a nasal passage wall ofthe biological subject.
 130. The method of claim 112, further comprisingimplanting a dental implant, wherein the dental implant is configuredfor electrical communication with the patency element.
 131. The methodof claim 112, further comprising filling a dental cavity with conductivedental filling for electrical communication with the patency element.132. The method of claim 132, further comprising implanting a coil inthe head and/or neck region of the biological subject.
 133. The methodof claim 133, wherein the coil is an inductive coil.
 134. The method ofclaim 112, further comprises placement of a dermal patch for patencyelement activation.
 135. A system for maintaining airway patency in abiological subject comprising: an implantable patency element thatchanges shape in response to an electrical stimulus; an implantabletransducer; an implantable lead wire connecting the patency element andthe transducer; a removable transducer; and a removable power sourceconfigured to supply electrical power to the removable transducer,wherein the implantable patency element comprises an electroactivepolymer.